MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 09/21/2020

Event Type  Injury  

Event Description

Chemical burn; my (b)(6) yr old has type 1 diabetes.She was diagnosed at (b)(6).She has been using a cgm dexcom 6 for 1 yr without incident.We recently received a new batch of sensors.We put 1 on my childs abdomen 3 days ago.Today she was complaining that it hurt so we took it off.The skin area where the adhesive was on the sensor is red, and looks like a chemical burn.Contacted dexcom and they stated that they have recently changed the adhesive formula.I belong to numerous type 1 diabetes groups after i mentioned this a lot other people, mostly children are now having this issue as well.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10579597
• MDR Text Key: 208588618
• Report Number: MW5096833
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 24